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Completed

NCT Number: NCT02499939

Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN)

The primary purpose of the trial is to determine the preliminary efficacy of therapeutic ultrasound in the treatment of pain and sensory disturbance related to chemotherapy induced peripheral neuropathy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6J4P9, Canada

About this study

Thirty cancer patients with colon or colorectal cancer undergoing chemotherapy treatment including the agent oxaliplatin will take part in the study. Patients will be randomly assigned to either standard care alone (education and therapeutic exercises) or standard care plus 10 treatments of therapeutic ultrasound to the toes and fingers.

Participants in both groups will follow a home exercise program for a 6 week period. Therapeutic ultrasound will be administered daily (e.g., Monday to Friday) over the first two week period of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults18 or older,
  • receiving or have received chemotherapy treatment for colon or colorectal cancer,
  • chemotherapy regimen includes the agent oxaliplatin,
  • Grade 1, 2 or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy.

Exclusion criteria

  • neuropathy pre-existing the patient's cancer diagnosis;
  • contraindications to therapeutic ultrasound:
  • active cancer in region of hands or feet,
  • presence of deep vein thrombosis,
  • lack of sensation in hands or feet,
  • metal or plastic implants in hands or feet;
  • peripheral vascular disease or other serious existing non-malignant disease which may affect their ability to complete testing and treatment sessions.

Treatment and study plan

Standard Care

Behavioral

Education and home exercises

ultrasound therapy

Other

Ultrasound is a therapeutic modality that is used by physical therapists to help reduce local tissue pain and inflammation. Ultrasound is applied using a round-headed wand or probe that is placed in direct contact with the patient's skin. Ultrasound gel is used on all surfaces of the ultrasound head to reduce friction and assist in the transmission of the ultrasonic waves. For the purposes of treatment for CIPN, the ultrasound will be applied for 5 minutes to each limb (right toes, left toes, right fingers, left fingers) at frequency of 3.0 megahertz (MHz) and an intensity of 0.7-0.8 watts per cm2.

(For CIPN, the ultrasound will be administered at a lower intensity in order to avoid a heating effect on the tissues.)

Primary outcomes

  1. Functional Assessment of Cancer Therapy Gynecological Oncology Group Neurotoxicity-12 item scale

    Time frame: 6 weeks

    Change in pain and sensory disturbance

Secondary outcomes

  1. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)3

    Time frame: 6 weeks

    Change in quality of life and symptoms related to chemotherapy induced peripheral nerve injury

  2. Protective sensation

    Time frame: 6 weeks

    Change in protective sensation: using a 10g monofilament for the feet and 6g for the hands to determine presence or absence of protective sensation.

  3. Temperature sensation

    Time frame: 6 weeks

    Change in temperature sensation: hot and cold test tubes will be applied to the feet and hands to determine ability to distinguish hot and cold sensations.

  4. Vibration sensation

    Time frame: 6 weeks

    Change in vibration sensation: A 128 Hz tuning fork will be applied to the big toe, medial malleolus, thumb and ulnar styloid to determine presence/ absence of vibration sensation.

  5. Reflexes

    Time frame: 6 weeks

    Change in reflexes: The reflex of the Achilles tendon will be tested to determine the presence/ absence of this tendon reflex

  6. Balance Assessment

    Time frame: 6 weeks

    Change in two foot and single foot balance: balance will be assessed in two conditions: eyes open and eyes closed.

Sponsors and collaborators

Lead sponsor

Margie McNeely

Other

Collaborators

  • Cross Cancer Institute

Registry information

Official study title

Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN) in Colon and Colorectal Cancer Patients: A Randomized Controlled Pilot Trial

Acronym: ULTRA

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 16, 2015
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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